(39 days)
Not Found
No
The device description details a lateral flow immunoassay with light reflection for detection and a display screen for results. There is no mention of AI/ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
This device is a diagnostic tool used to detect hCG in urine for early pregnancy detection; it does not treat or prevent any medical condition.
Yes
The device is explicitly stated to be for "qualitative detection of hCG in human urine as an aid in early detection of pregnancy. For in vitro diagnostic use." This statement directly indicates its intended use as a diagnostic device.
No
The device description explicitly states it consists of a test strip assembled in a plastic housing with an absorbent tip, and uses lateral flow immunoassay and light reflection for detection, indicating it is a physical hardware device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "For in vitro diagnostic use, for over the counter use."
The "Device Description" also mentions: "Shinetell™ Digital Pregnancy Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine..."
These statements clearly indicate that the device is intended for diagnostic testing performed outside of the body (in vitro) using biological samples (urine).
N/A
Intended Use / Indications for Use
ShinetellTM Digital Pregnancy Test is a pregnancy test. It is used for the qualitative detection of hCG in human urine as an aid in early detection of pregnancy. For in vitro diagnostic use, for over the counter use.
Product codes (comma separated list FDA assigned to the subject device)
LCX
Device Description
Shinetell™ Digital Pregnancy Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-to-use format.
Shinetell™ Digital Pregnancy Test uses lateral flow immunoassay and light reflection for the detection of the HCG in urine specimens. The test would detect the light intensity by using the LED as the light source. After that, the result can be displayed on the display screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over the counter use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
A. Analytical performance:
Negative female urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 12.5, 15, 18.75, 22.5, 25, 50, 100 and 200 mIU/mL. Each sample was tested by both dip and midstream methods in 10 replicates per day for 5 days for each device lot. Total of three device lots were tested. Tests were performed by three different operators for each sample concentration.
To evaluate specificity, 300 female urine samples were collected from healthy, non-pregnant females in pre-menopausal (ages 1840 years old), peri-menopausal (4155 years old), and post-menopausal (>55 years old) groups. A total of 100 samples from each age group were collected and these samples were tested by lay persons using both dip and midstream methods.
To evaluate cross-reactivity, negative and positive female urine samples (0, 5 and 25 mIU/mL hCG) were spiked with potential cross reactants (500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH).
To evaluate the effect of the hCG ß-core fragment, negative female urine samples (0 and 5 mIU/mL hCG) and positive female urine samples (25 and 20,000 mIU/mL hCG) were spiked with hCG ß-core fragment (hCGBcf) at concentrations of 50,000 pmol/L, 125,000 pmol/L, 250,000pmol/L, and 500,000pmol/L.
To evaluate potential interferers with Shinetell™ Digital Pregnancy Test, urine samples containing 0, 5 and 25 mIU/mL hCG were spiked with the interfering substance to obtain the certain desired test concentration.
To evaluate the effect of urine pH on the results of Shinetell™ Digital Pregnancy Test, urine samples containing 0, 5 and 25 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9.
To evaluate the effect of urine density on the results of Shinetell™ Digital Pregnancy Test, urine samples containing 0, 5 and 25 mIU/mL hCG were tested at density values of 1.000, 1.004, 1.009, 1.015, 1.021, 1.026, 1.029 and 1.035.
B. Method comparison study: Urine samples were collected from 200 women presenting to test for pregnancy. All subjects were suspected to be pregnant and they are all in the early stage of less than 5 weeks. All samples were tested with candidate and predicate devices at three POC sites (3 different professionals using the candidate device and 1 professional using the predicate device at each site).
C. Lay person study:
First study: 200 women's individual pregnancy status was self-tested. Individuals with varying educational and occupational backgrounds from three sites were chosen for the study. Each subject tested her own urine sample using the device according to the package insert and provided a sample for professional testing.
Second study: Negative urine sample pools were spiked with 5 mIU/mL hCG and 25 mIU/mL hCG. All aliquots were blind labeled by the person who prepared the samples and didn't take part in the sample testing. Both laypersons and professionals use dip method to test the above samples. 100 laypersons tested the 5 mIU/mL hCG aliquots and 100 laypersons tested the 25 mIU/mL hCG aliquots. Each testing site had a study administrator to observe or monitor the studies by laypersons without providing assistance to the participants.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. Analytical performance
Precision/Reproducibility/Sensitivity:
- hCG concentrations of 0, 12.5, 15, 18.75, 22.5, 25, 50, 100 and 200 mIU/mL.
- Dip Testing: 150 replicates for each concentration.
- Midstream Testing: 150 replicates for each concentration.
- Overall Testing: 300 replicates for each concentration.
- Key results: Based on the results, the sensitivity of Shinetell™ Digital Pregnancy Test is demonstrated to be 25 mIU/mL.
Hook effect test:
- hCG concentrations of 6,250 mlU/mL, 12,500 mIU/mL, 25,000 mIU/mL, 50,000 mIU/mL, 100,000 mIU/mL, 200,000 mIU/mL, and 500,000 mIU/mL.
- Key results: All tested concentrations gave a positive result. No hook effect was observed at hCG concentration up to 500,000 mIU/mL.
Specificity:
- 300 female urine samples from pre-menopausal, peri-menopausal, and post-menopausal groups (100 samples per group).
- Key results: No false positive results were observed for any of the age groups.
Cross-reactivity:
- Negative and positive female urine samples (0, 5 and 25 mIU/mL hCG) spiked with potential cross reactants (500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH).
- Key results: No cross-reactivity was observed at tested concentration.
Effect of hCG ß-core fragment:
- Negative female urine samples (0 and 5 mIU/mL hCG) and positive female urine samples (25 and 20,000 mIU/mL hCG) spiked with hCGBcf at concentrations of 50,000 pmol/L, 125,000 pmol/L, 250,000pmol/L, and 500,000pmol/L.
- Key results: The performance of Shinetell™ Digital Pregnancy Test is not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.
Interfering substance:
- Urine samples containing 0, 5 and 25 mIU/mL hCG spiked with various interfering substances at specified concentrations.
- Key results: No interference effect was observed at the tested concentration.
Effect of urine pH:
- Urine samples containing 0, 5 and 25 mIU/mL hCG tested at pH values of 4, 5, 6, 7, 8 and 9.
- Key results: Urine pH ranges between 4 and 9 does not affect the performance of Shinetell™ Digital Pregnancy Test.
Effect of urine density:
- Urine samples containing 0, 5 and 25 mIU/mL hCG tested at density values of 1.000, 1.004, 1.009, 1.015, 1.021, 1.026, 1.029 and 1.035.
- Key results: Urine with a relative density of 1.000 to 1.035 does not affect the performance of Shinetell™ Digital Pregnancy Test.
B. Method comparison study:
- Study type: Comparison with predicate device.
- Sample size: 200 women.
- Key results: The conformity between Shinetell™ Digital Pregnancy Test (midstream method / dip method) and the predicate device is 100%.
C. Lay person study:
First study:
- Study type: Self-testing.
- Sample size: 200 women.
- Key results: The lay person results showed 100% positive and 100% negative conformity with the professional results.
Second study:
- Study type: Layperson and professional testing of spiked samples.
- Sample size: 100 laypersons for 5 mIU/mL hCG aliquots and 100 laypersons for 25 mIU/mL hCG aliquots.
- Key results: 100% correct results for both 5 mIU/mL and 25 mIU/mL hCG aliquots. Consumers found the test easy to use and had no trouble understanding the labeling and interpreting the results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: 25 mIU/mL
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
MissLan™ Digital Pregnancy Rapid Test (K222305)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1155 Human chorionic gonadotropin (HCG) test system.
(a)
Human chorionic gonadotropin (HCG) test system intended for the early detection of pregnancy —(1)Identification. A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class II.(b)
Human chorionic gonadotropin (HCG) test system intended for any uses other than early detection of pregnancy —(1)Identification. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.(2)
Classification. Class III.(3)
Date PMA or notice of completion of a PDP is required. As of the enactment date of the amendments, May 28, 1976, an approval under section 515 of the act is required before the device described in paragraph (b)(1) may be commercially distributed. See § 862.3.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" on the bottom.
August 13, 2024
Hangzhou AllTest Biotech Co., Ltd. % Jenny Xia Director LSI International Inc. 504 East Diamond Ave., Suite H Gaithersburg, Maryland 20877
Re: K241978
Trade/Device Name: Shinetell™ Digital Pregnancy Test Regulation Number: 21 CFR 862.1155 Regulation Name: Human Chorionic Gonadotropin (HCG) Test System Regulatory Class: Class II Product Code: LCX Dated: July 4, 2024 Received: July 5, 2024
Dear Jenny Xia:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Paula V. Caposino -S
Paula Caposino, Ph.D. Deputy Division Director Division of Chemistry and Toxicology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
K241978 Device Name
ShinetellTM Digital Pregnancy Test
Indications for Use (Describe)
ShinetellTM Digital Pregnancy Test is a pregnancy test. It is used for the qualitative detection of hCG in human urine as an aid in early detection of pregnancy. For in vitro diagnostic use, for over the counter use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY K241978
| 1. | Date: | July 1, 2024 |
|---|---|---|
| 2. | Submitter: | Hangzhou AllTest Biotech Co., Ltd. |
| No. 550 Yinhai Street | ||
| Hangzhou, China | ||
| 3. | Contact person: | Jenny Xia |
| LSI International Inc. | ||
| 504 East Diamond Ave., Suite H | ||
| Gaithersburg, MD 20877 | ||
| Telephone: 301-525-6856 | ||
| Fax: 301-916-6213 | ||
| Email: jxia@lsi-consulting.org | ||
| 4. | Device Name: | Shinetell™ Digital Pregnancy Test |
| Classification: | Class II | |
| Product Code: | LCX | |
| CFR: | 862.1155 | |
| 5. | Predicate Devices: | MissLan™ Digital Pregnancy Rapid Test (K222305) |
6. Intended Use
Shinetell™ Digital Pregnancy Test is a pregnancy test. It is used for the qualitative detection of hCG in human urine as an aid in early detection of pregnancy. For in vitro diagnostic use, for over the counter use.
7. Device Description
Shinetell™ Digital Pregnancy Test is used for in vitro qualitative detection of Human Chorionic Gonadotropin (HCG) in human urine, and is designed to be tested in dip or midstream mode. The test device consists of a single test strip assembled in a plastic housing, with an absorbent tip. The device is in a ready-touse format.
Shinetell™ Digital Pregnancy Test uses lateral flow immunoassay and light reflection for the detection of the HCG in urine specimens. The test would detect the light intensity by using the LED as the light source. After that, the result can be displayed on the display screen.
Substantial Equivalence Information 8.
| Similarities | ||
|---|---|---|
| Item | Candidate device | Predicate device |
1
4
| Intended use | Early detection of
pregnancy | Early detection of
pregnancy |
|--------------------|---------------------------------|---------------------------------|
| Specimen | Urine | Urine |
| Assay technical | Immunochromatographic
assay | Immunochromatographic
assay |
| Sensitivity | 25 mIU/mL | 25 mIU/mL |
| Results | Qualitative | Qualitative |
| Target user | Over the counter use | Over the counter use |
| Sample application | Midstream and dip
methods | Midstream and dip methods |
| Readout | Digital/LCD screen | Digital/LCD screen |
| Differences | | |
| Item | Device | Predicate |
| Appearance | 152.4 x 24 x 16.5 mm | 155.5 x 21.5 x 14.5 mm |
| Display Results | "Pregnant" or "Not
Pregnant" | "+" or "-" |
9. Test Principle
Human chorionic gonadotropin (HCG) is a glycoprotein produced by the placenta during pregnancy. Shinetell™ Digital Pregnancy Test uses lateral flow immunoassay and light reflection for the detection of the HCG in urine specimens. After the appropriate urine sample is added to the absorbent tip, the clock symbol will appear and blink on the Display Screen after urine is applied, indicating the test is working. The HCG in urine specimen will react with the anti-ß-HCG antibody-colloidal gold conjugate and form a compound. As the liquid flows to the Test area of the test strip, the compound will be captured by the anti-a-HCG antibody immobilized on the Test area, then a colored line will be formed on the Test area.
The test midstream would detect the light intensity by using the LED as the light source. The background of the LED lighted zone will be darker due to the color of colloidal gold conjugate, and the intensity of the reflected light received by the photodiode decreases significantly. By detecting the signal parameter of the reflected light intensity, which is decreasing significantly, the test midstream can determine that the sample is adding properly. The LED light will irradiate the test strip and then be reflected to the photodiode and the photodiode can respond to the different light intensity value by testing the intensity of reflected light.
In approximately 3 minutes, the result will be shown on the display screen. If test value is over the preset threshold, the test result is positive and "Pregnant" is displayed on the screen. Otherwise, the result is negative and "Not Pregnant" is displayed on the screen.
If the sample is adding improperly, the background color of the LED lighted zone
5
does not decrease significantly. By detecting the signal parameter of the reflected light intensity, which isn't decreasing significantly, the test midstream can determine that the sample is adding improperly, and the test will be invalid and "?" is displayed on the screen.
10. Performance Characteristics
A. Analytical nerformance
a. Precision/Reproducibility/Sensitivity
Negative female urine was spiked with hCG standard (Traceable to the 5th WHO) to hCG concentrations of 0, 12.5, 15, 18.75, 22.5, 25, 50, 100 and 200 mIU/mL. Each sample was tested by both dip and midstream methods in 10 replicates per day for 5 days for each device lot. Total of three device lots were tested. Tests were performed by three different operators for each sample concentration. The results are summarized in the table below:
| hCG
Concentration
(mIU/mL) | Operator 1
Lot 1 | | Operator 2
Lot 2 | | Operator 3
Lot 3 | | Total
result | | %
Negative | %
Positive |
|----------------------------------|---------------------|----|---------------------|----|---------------------|----|-----------------|-----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 12.5 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 15 | 22 | 28 | 24 | 26 | 23 | 27 | 69 | 81 | 46% | 54% |
| 18.75 | 13 | 37 | 12 | 38 | 12 | 38 | 37 | 113 | 25% | 75% |
| 22.5 | 5 | 45 | 5 | 45 | 5 | 45 | 15 | 135 | 10% | 90% |
| 25 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 100 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 200 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
Midstream Testing
Dip Testing
| hCG
Concentration
(mIU/mL) | Operator
1
Lot 1 | | Operator
2
Lot 2 | | Operator
3
Lot 3 | | Total
result | | %
Negative | %
Positive |
|----------------------------------|------------------------|----|------------------------|----|------------------------|----|-----------------|-----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 12.5 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0 | 100% | 0% |
| 15 | 23 | 27 | 25 | 25 | 25 | 25 | 73 | 77 | 49% | 51% |
| 18.75 | 12 | 38 | 13 | 37 | 12 | 38 | 37 | 113 | 25% | 75% |
| 22.5 | 5 | 45 | 6 | 44 | 5 | 45 | 16 | 134 | 11% | 89% |
| 25 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 50 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
| 100 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
6
| 200 | 0 | 50 | 0 | 50 | 0 | 50 | 0 | 150 | 0% | 100% |
|---|---|---|---|---|---|---|---|---|---|---|
| ----- | --- | ---- | --- | ---- | --- | ---- | --- | ----- | ---- | ------ |
| hCG
Concentration
(mIU/mL) | Lot 1 | | Lot 2 | | Lot 3 | | Total
result | | %
Negative | %
Positive |
|----------------------------------|-------|-----|-------|-----|-------|-----|-----------------|-----|---------------|---------------|
| | - | + | - | + | - | + | - | + | | |
| 0 | 100 | 0 | 100 | 0 | 100 | 0 | 300 | 0 | 100% | 0% |
| 12.5 | 100 | 0 | 100 | 0 | 100 | 0 | 300 | 0 | 100% | 0% |
| 15 | 45 | 55 | 49 | 51 | 48 | 52 | 142 | 158 | 47% | 53% |
| 18.75 | 25 | 75 | 25 | 75 | 24 | 76 | 74 | 226 | 25% | 75% |
| 22.5 | 10 | 90 | 11 | 89 | 10 | 90 | 31 | 269 | 10% | 90% |
| 25 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 300 | 0% | 100% |
| 50 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 300 | 0% | 100% |
| 100 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 300 | 0% | 100% |
| 200 | 0 | 100 | 0 | 100 | 0 | 100 | 0 | 300 | 0% | 100% |
Overall Testing
Shinetell™ Digital Pregnancy Test exhibited reproducible results.
Based on the above results, the sensitivity of Shinetell™ Digital Pregnancy Test is demonstrated to be 25 mIU/mL.
b. Linearity/assay reportable range:
Linearity is not applicable since this is a qualitative test. The test device was evaluated for high dose or hook effect.
Hook effect test:
Negative female urine samples were spiked with varying hCG concentrations (6,250 mlU/mL, 12,500 mIU/mL, 25,000 mIU/mL, 50,000 mIU/mL, 100,000 mIU/mL, 200,000 mIU/mL, and 500,000 mIU/mL) and were tested with 3 lots of the candidate device. All tested concentrations gave a positive result. The results demonstrated that no hook effect was observed at hCG concentration up to 500,000 mIU/mL.
c. Traceability, Stability, Expected values (controls, calibrators, or methods): Traceability:
Shinetell™ Digital Pregnancy Test is calibrated against reference material traceable to WHO International Standard 5th edition, NIBSC code 07/364.
Stability:
Shinetell™ Digital Pregnancy Test is stable for 24 months at 2°C to 30°C based on real time stability study.
d. Specificity and cross reactivity
To evaluate specificity, 300 female urine samples were collected from healthy,
7
non-pregnant females in pre-menopausal (ages 1840 years old), peri-menopausal (4155 years old), and post-menopausal (>55 years old) groups. A total of 100 samples from each age group were collected and these samples were tested by lay persons using both dip and midstream methods. No false positive results were observed for any of the age groups.
To evaluate cross-reactivity, negative and positive female urine samples (0, 5 and 25 mIU/mL hCG) were spiked with potential cross reactants (500 mIU/mL hLH, 1000 mIU/mL hFSH, 1000 µIU/mL hTSH). No cross-reactivity was observed at tested concentration.
To evaluate the effect of the hCG ß-core fragment, negative female urine samples (0 and 5 mIU/mL hCG) and positive female urine samples (25 and 20,000 mIU/mL hCG) were spiked with hCG ß-core fragment (hCGBcf) at concentrations of 50,000 pmol/L, 125,000 pmol/L, 250,000pmol/L, and 500,000pmol/L. The performance of Shinetell™ Digital Pregnancy Test is not affected by hCG ß-core fragment concentrations up to 500,000 pmol/L.
e. Interfering substance
To evaluate potential interferers with Shinetell™ Digital Pregnancy Test, urine samples containing 0, 5 and 25 mIU/mL hCG were spiked with the interfering substance to obtain the certain desired test concentration. No interference effect was observed at the tested concentration shown in table below:
| Substance | Concentration |
|---|---|
| Glucose | 2000 mg/dL |
| Albumin | 2000 mg/dL |
| Bilirubin | 40 mg/dL |
| Hemoglobin | 1000 mg/dL |
| Uric acid | 23.5 mg/dL |
| Acetaminophen | 20 mg/dL |
| Amoxicillin | 20 mg/dL |
| Aspirin | 80 mg/dL |
| Gentisic acid | 20 mg/dL |
| Salicylic Acid | 20 mg/dL |
| Ascorbic acid | 20 mg/dL |
| Folic acid | 0.03 mg/dL |
| Vitamin B1 | 80 mg/dL |
| Atropine | 20 mg/dL |
| Caffeine | 20 mg/dL |
| Tetracycline | 20 mg/dL |
| Ampicillin | 20 mg/dL |
| Ibuprofen | 40 mg/dL |
| Pregnanediol | 1.5 mg/dL |
| β-hydroxybutyrate | 2000 mg/dL |
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| EDTA | 80 mg/dL |
|---|---|
| Ethanol | 1% |
| Ketone | 20 mg/dL |
| Thiophene | 20 mg/dL |
| Benzoylecgonine | 10 mg/dL |
| Cannabinol | 10 mg/dL |
| Ephedrine | 20 mg/dL |
| Phenylpropanolamine | 20 mg/dL |
| Phenothiazine | 20 mg/dL |
To evaluate the effect of urine pH on the results of Shinetell™ Digital Pregnancy Test, urine samples containing 0, 5 and 25 mIU/mL hCG were tested at pH values of 4, 5, 6, 7, 8 and 9. The results indicated that urine pH ranges between 4 and 9 does not affect the performance of Shinetell™ Digital Pregnancy Test.
To evaluate the effect of urine density on the results of Shinetell™ Digital Pregnancy Test, urine samples containing 0, 5 and 25 mIU/mL hCG were tested at density values of 1.000, 1.004, 1.009, 1.015, 1.021, 1.026, 1.029 and 1.035. The results indicated that urine with a relative density of 1.000 to 1.035 does not affect the performance of Shinetell™ Digital Pregnancy Test.
B. Method comnarison studv
Method comparison with predicate device
The performance of the new device was compared to the predicate test. Urine samples were collected from 200 women presenting to test for pregnancy. All subjects were suspected to be pregnant and they are all in the early stage of less than 5 weeks. All samples were tested with candidate and predicate devices at three POC sites (3 different professionals using the candidate device and 1 professional using the predicate device at each site).
| Summary midstream testing results | ||||
|---|---|---|---|---|
| Midstream method | Predicate device | |||
| Positive | Negative | Total | ||
| Candidate device | Positive | 52 | 0 | 52 |
| Negative | 0 | 48 | 48 | |
| Total | 52 | 48 | 100 |
| Summary dip testing results | ||||
|---|---|---|---|---|
| Dip method | Predicate device | |||
| Positive | Negative | Total | ||
| Candidate device | Positive | 41 | 0 | 41 |
| Negative | 0 | 59 | 59 | |
| Total | 41 | 59 | 100 |
marv din tocting rocult
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The conformity between Shinetell™ Digital Pregnancy Test (midstream method / dip method) and the predicate device is 100%.
C. Lav person study
First study:
200 women's individual pregnancy status was self-tested. Individuals with varying educational and occupational backgrounds from three sites were chosen for the study. Each subject tested her own urine sample using the device according to the package insert and provided a sample for professional testing.
Summary
| Midstream method | Professional | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Layperson | Positive | 47 | 0 | 47 |
| Negative | 0 | 53 | 53 | |
| Total | 47 | 53 | 100 |
| Dip method | Professional | |||
|---|---|---|---|---|
| Positive | Negative | Total | ||
| Layperson | Positive | 46 | 0 | 46 |
| Negative | 0 | 54 | 54 | |
| Total | 46 | 54 | 100 |
From the above tables, the lay person results showed 100% positive and 100% negative conformity with the professional results.
Second study:
Negative urine sample pools were spiked with 5 mIU/mL hCG and 25 mIU/mL hCG. All aliquots were blind labeled by the person who prepared the samples and didn't take part in the sample testing. Both laypersons and professionals use dip method to test the above samples. 100 laypersons tested the 5 mIU/mL hCG aliquots and 100 laypersons tested the 25 mIU/mL hCG aliquots. Each testing site had a study administrator to observe or monitor the studies by laypersons without providing assistance to the participants.
| hCG
Concentration
(mIU/mL) | Lay person result | | Professional result | | The percentage of
correct results (%) |
|----------------------------------|--------------------|--------------------|---------------------|--------------------|------------------------------------------|
| 5 | No. of
Positive | No. of
Negative | No. of
Positive | No. of
Negative | |
| 5 | 0 | 100 | 0 | 100 | 100% |
| 25 | 100 | 0 | 100 | 0 | 100% |
Each lay person was given a questionnaire to assess the readability of the labeling. The results of the questionnaire reflected that the consumers found the test easy to use and that they did not have trouble understanding the labeling and interpreting the results.
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11. Conclusion
Based on the test principle and performance characteristics of the device including precision, interference, specificity, method comparison and lay-user studies of the device, it's concluded that Shinetell™ Digital Pregnancy Test is substantially equivalent to the predicate.